The Clinical Utility of Cholangioscopy and Pancreatoscopy in the Diagnosis and Management of Pancreaticobiliary Disorders

Completed

• Conditions: Disorders of the Pancreas and Biliary Tree
• Interventions: Other: ERCP as per medical indication

• Registration Number: NCT00861198
• Lead Sponsor: University of Florida

Brief Summary

At the time of endoscopic retrograde cholangiopancreatography (ERCP) examination of the pancreaticobiliary system is done indirectly by radiologic means. Contrast is injected into the bile and/or pancreatic duct and outline of the duct is then viewed by fluoroscopic imaging. Frequently this is followed by diagnostic maneuvers (tissue acquisition) or therapeutic interventions (stone removal, stent insertion). Direct visualization of the bile and pancreatic ducts (cholangioscopy/pancreatoscopy) was developed 15 years ago and was shown to be superior to the indirect radiological view. The procedure did not become widely used secondary to high procedure related costs and equipment prone to failure. Recently a much improved (more affordable and more durable) cholangioscope was developed and approved by the FDA. The goal of this study is to prospectively record our experience with cholangioscopy and pancreatoscopy performed as medically indicated as part of standard medical care.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11
• Study First Submitted: 2009-03-12
• Study First Submitted QC: 2009-03-12
• Study First Posted: 2009-03-13
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Status Verified: 2015-06
• Results First Submitted: 2015-06-29
• Results First Submitted QC: 2015-06-29
• Last Update Submitted: 2015-06-29
• Results First Posted: 2015-07-27
• Last Update Posted: 2015-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

• Subject is 18 years or older.
• Scheduled to undergo ERCP with cholangioscopy and/or pancreatoscopy at the University of Florida, Gainesville, FL as medically indicated.
• Subject must be able to give informed consent

Exclusion Criteria

• Any contraindication to ERCP.
• The subject is unable to give informed consent.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ERCP	ERCP as per medical indication	Patients who have a medical indication for ERCP with cholangioscopy and/or pancreatoscopy and are referred for the procedure as part of their standard medical care will be considered for the study.

Primary Outcome Measures

Name	Time	Method
Successful Procedure Completion	baseline	Defined based on the indication for SpyGlass. For cases involving biliary or pancreatic stones the procedure was considered successful when complete stone clearance was accomplished. For cases involving established or suspected nonstone-related lesions of the pancreatobiliary system, success was defined when all of the following criteria were met: successful advancement of the SpyScope to the desired target, adequate visualization of the area of interest and successful applications of all diagnostic and/or therapeutic maneuvers that were deemed necessary based on the endoscopic findings.

Trial Locations

Locations (1)

Shands UF endoscopy Center; 🇺🇸 Gainesville, Florida, United States